Study of Adjuvant ONO-4538 With Resected Gastric Cancer

December 7, 2023 updated by: Ono Pharmaceutical Co. Ltd

A Multicenter, Double-blind, Randomized Study in Patients With Gastric Cancer Undergoing Postoperative Adjuvant Chemotherapy

The purpose of study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with Nivolumab in combination with tegafur-gimeracil-oteracil potassium (S-1 therapy) or capecitabine + oxaliplatin (CapeOX therapy), in comparison with placebo in combination with S-1 therapy or CapeOX therapy, in pStage III gastric cancer (including esophagogastric junction cancer) after D2 or more extensive lymph node dissection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Anhui Province, China
        • Anhui Province Clinical Site
      • Beijing, China
        • Beijing Clinical Site1
      • Beijing, China
        • Beijing Clinical Site2
      • Cuangdong Province, China
        • Cuangdong Province Clinical Site
      • Guangdong Province, China
        • Guangdong Province Clinical Site1
      • Guangdong Province, China
        • Guangdong Province Clinical Site2
      • Henan Province, China
        • Henan Province Clinical Site1
      • Henan Province, China
        • Henan Province Clinical Site2
      • Jiangsu Province, China
        • Jiangsu Province Clinical Site1
      • Jiangsu Province, China
        • Jiangsu Province Clinical Site3
      • Jiangsu Province, China
        • Jiangsu Province Clinical Site4
      • Jiangsu Province, China
        • Jiangsu Province Clinical Site5
      • Jiangsu Province, China
        • Jiangsu Province Clinical Site6
      • Jiangxi Province, China
        • Jiangxi Province Clinical Site2
      • Jilin Province, China
        • Jilin Province Clinical Site
      • Liaoning Province, China
        • Liaoning Province Clinical Site
      • Shanxi Province, China
        • Shanxi Province Clinical Site
      • Tianjin, China
        • Tianjin Clinical Site1
      • Tianjin, China
        • Tianjin Clinical Site2
      • Zhejiang Province, China
        • Zhejiang Province Clinical Site
      • Zhengjiang Province, China
        • Zhengjiang Province Clinical Site
  • Japan
      • Chiba, Japan
        • Chiba Clinical Site
      • Fukuoka, Japan
        • Fukuoka Clinical Site 1
      • Fukuoka, Japan
        • Fukuoka Clinical site 2
      • Gifu, Japan
        • Gifu Clinical site
      • Hiroshima, Japan
        • Hiroshima Clinical Site1
      • Hiroshima, Japan
        • Hiroshima Clinical Site2
      • Hiroshima, Japan
        • Hiroshima Clinical Site3
      • Kochi, Japan
        • Kochi Clinical Site
      • Kumamoto, Japan
        • Kumamoto Clinical site
      • Kyoto, Japan
        • Kyoto Clinical Site
      • Niigata, Japan
        • Niigata Clinical Site
      • Osaka, Japan
        • Osaka Clinical Site1
      • Osaka, Japan
        • Osaka Clinical Site2
      • Osaka, Japan
        • Osaka Clinical Site3
      • Osaka, Japan
        • Osaka Clinical Site4
      • Shizuoka, Japan
        • Shizuoka Clinical site
      • Toyama, Japan
        • Toyama Clinical Site
      • Wakayama, Japan
        • Wakayama Clinical Site
      • Yamagata, Japan
        • Yamagata Clinical Site
    • Aichi
      • Nagoya, Aichi, Japan
        • Aichi Clinical Site1
      • Nagoya, Aichi, Japan
        • Aichi Clinical Site2
    • Chiba
      • Kamogawa, Chiba, Japan
        • Chiba Clinical Site
    • Ehime
      • Matsuyama, Ehime, Japan
        • Ehime Clinical Site
      • Matsuyama, Ehime, Japan
        • Ehime Clinicla Site
    • Gifu
      • Ōgaki, Gifu, Japan
        • Gifu Clinical site
    • Gunma
      • Ota, Gunma, Japan
        • Gunma Clinical Site
      • Takasaki, Gunma, Japan
        • Gunma Clinical Site
    • Hiroshima
      • Fukuyama, Hiroshima, Japan
        • Hiroshima Clinical Site
    • Hokkaido
      • Hakodate, Hokkaido, Japan
        • Hokkaido Clinical Site 3
      • Sapporo, Hokkaido, Japan
        • Hokkaido Clinical Site 1
      • Sapporo, Hokkaido, Japan
        • Hokkaido Clinical Site2
    • Hyogo
      • Akashi, Hyogo, Japan
        • Hyogo Clinical Site
      • Amagasaki, Hyogo, Japan
        • Hyogo Clinical Site
      • Nishinomiya, Hyogo, Japan
        • Hyogo Clinical Site
    • Ishikawa
      • Kanazawa, Ishikawa, Japan
        • Ishikawa Clinical Site
    • Iwate
      • Morioka, Iwate, Japan
        • Iwate Clinical Site
    • Kanagawa
      • Sagamihara, Kanagawa, Japan
        • Kanagawa Clinical Site
      • Yokohama, Kanagawa, Japan
        • Kanagawa Clinical Site
    • Miyagi
      • Osaki, Miyagi, Japan
        • Miyagi Clinical Site
    • Nagano
      • Saku, Nagano, Japan
        • Nagano Clinical Site
    • Okayama
      • Kurashiki, Okayama, Japan
        • Okayama Clinical site
    • Osaka
      • Hirakata, Osaka, Japan
        • Osaka Clinical site
      • Sakai, Osaka, Japan
        • Osaka Clinical site
      • Suita, Osaka, Japan
        • Osaka Clinical site
      • Takatsuki, Osaka, Japan
        • Osaka Clinical site
      • Toyonaka, Osaka, Japan
        • Osaka Clinical site
      • Ōsaka-sayama, Osaka, Japan
        • Osaka Clinical site
    • Saitama
      • Hidaka, Saitama, Japan
        • Saitama Clinical site
      • Kitaadachi-gun, Saitama, Japan
        • Saitama Clinical site
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan
        • Shizuoka Clinical site
    • Tochigi
      • Shimotsuke, Tochigi, Japan
        • Tochigi Clinical site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan
        • Tokyo Clinical site
      • Chuo-ku, Tokyo, Japan
        • Tokyo Clinical site
      • Koto-ku, Tokyo, Japan
        • Tokyo Clinical site
      • Shinjuku-ku, Tokyo, Japan
        • Tokyo Clinical site
  • Korea, Republic of
      • Busan, Korea, Republic of
        • Busan Clinical Site1
      • Busan, Korea, Republic of
        • Busan Clinical Site2
      • Busan, Korea, Republic of
        • Busan Clinical Site3
      • Daegu, Korea, Republic of
        • Daegu Clinical Site1
      • Daegu, Korea, Republic of
        • Daegu Clinical Site2
      • Daegu, Korea, Republic of
        • Daegu Clinical Site3
      • Daejeon, Korea, Republic of
        • Daejeon Clinical Site 1
      • Daejeon, Korea, Republic of
        • Daejeon Clinical Site 2
      • Gwangju, Korea, Republic of
        • Gwangju Clinical Site
      • Gyeonggi-do, Korea, Republic of
        • Gyeonggi-do Clinical Site1
      • Gyeonggi-do, Korea, Republic of
        • Gyeonggi-do Clinical Site2
      • Gyeonggi-do, Korea, Republic of
        • Gyeonggi-do Clinical Site3
      • Gyeonggi-do, Korea, Republic of
        • Gyeonggi-do Clinical Site4
      • Gyeonggi-do, Korea, Republic of
        • Gyeonggi-do Clinical Site5
      • Jeollabuk-do, Korea, Republic of
        • Jeollabuk-do Clinical Site
      • Seoul, Korea, Republic of
        • Seoul Clinical Site 8
      • Seoul, Korea, Republic of
        • Seoul Clinical Site 9
      • Seoul, Korea, Republic of
        • Seoul Clinical Site1
      • Seoul, Korea, Republic of
        • Seoul Clinical Site2
      • Seoul, Korea, Republic of
        • Seoul Clinical Site3
      • Seoul, Korea, Republic of
        • Seoul Clinical Site4
      • Seoul, Korea, Republic of
        • Seoul Clinical Site5
      • Seoul, Korea, Republic of
        • Seoul Clinical Site6
      • Seoul, Korea, Republic of
        • Seoul Clinical Site7
  • Taiwan
      • Kaohsiung, Taiwan
        • Kaohsiung Clinical Site2
      • Kaohsiung, Taiwan
        • Kaohsiung Clinical Site
      • New Taipei, Taiwan
        • New Taipei Clinical Site
      • Taichung, Taiwan
        • Taichung Clinical Site
      • Tainan, Taiwan
        • Tainan Clinical Site2
      • Tainan, Taiwan
        • Tainan Clinical Site
      • Taipei, Taiwan
        • Taipei Clinical Site1
      • Taipei, Taiwan
        • Taipei Clinical Site2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with histologically confirmed adenocarcinoma of the stomach
  • Patients without a remnant cancer (R0) who have undergone gastrectomy
  • Gastric carcinoma according to the stage classification of AJCC/UICC TNM Classification, 7th Edition on the basis of overall postoperative findings
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1

Exclusion Criteria:

  • Patients who have received non-surgical treatment (e.g., radiotherapy, chemotherapy, hormone therapy) for gastric cancer
  • Multiple primary cancers
  • A current or past history of severe hypersensitivity to any other antibody products
  • Any concurrent autoimmune disease or past history of chronic or recurrent autoimmune disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nivolumab group

Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).

Chemotherapy: S-1 Therapy or CapeOX Therapy is determined by the investigator.

S-1 therapy(maximum 1 year):

Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off

CapeOX Therapy(maximum 6 months):

Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.

Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.
Drug: Nivolumab
Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).
Other Names:
  • BMS-936558
  • MDX-1106
  • ONO-4538
Drug: Tegafur-gimeracil-oteracil potassium
Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off
Drug: Oxaliplatin
Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.
Drug: Capecitabine
Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.
Placebo Comparator: Placebo group

Placebo: Placebo solution intravenously for 30 min in every 3 weeks (maximum 1 year).

Chemotherapy: S-1 Therapy or CapeOX Therapy is determined by the investigator.

S-1 therapy(maximum 1 year):

Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off

CapeOX Therapy(maximum 6 months):

Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.

Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.
Drug: Tegafur-gimeracil-oteracil potassium
Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off
Drug: Oxaliplatin
Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.
Drug: Capecitabine
Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.
Drug: Placebo
Placebo: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relapse-free survival (RFS)
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: 5 years
5 years
3-year OS rate
Time Frame: 3 years
3 years
5-year OS rate
Time Frame: 5 years
5 years
3-year RFS rate
Time Frame: 3 years
3 years
5-year RFS rate
Time Frame: 5 years
5 years
Safety will be analyzed through the incidence of adverse events, serious adverse events
Time Frame: Up to 28 days from last dose
Up to 28 days from last dose
Safety will be analyzed through the incidence of laboratory abnormalities
Time Frame: Up to 28 days from last dose
Up to 28 days from last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharmaceutical Co. Ltd

Collaborators

Bristol-Myers Squibb

Investigators

  • Study Director: Project Leader, Ono Pharmaceutical Co. Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2017

Primary Completion (Actual)

August 17, 2022

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

December 27, 2016

First Submitted That Met QC Criteria

December 27, 2016

First Posted (Estimated)

December 30, 2016

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-4538-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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